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ALGOZAN® gel

Instruction manual

For medical use of the drug

Algosan®

(algozan)

Structure:

Active ingredients: diclofenac diethylamine, chestnut seed dry extract;

1 g of gel contains diclofenac diethylamine in terms of 100% substance - 15 mg, chestnut seed dry extract (Hippocastani semen extractum siccum) (5–7: 1), (extractant - 60% ethanol, excipient - maltodextrin) - 100 mg, in terms of escin - 5 mg;

excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), ethanol 96%, propylene glycol, carbomer, triethanolamine, purified water.

Dosage form.

Gel.

The main physicochemical properties: gel from light brown to tan, homogeneous consistency. Impregnations are allowed.

Pharmacotherapeutic group.

Nonsteroidal anti-inflammatory drugs for topical use. diclofenac, combinations.

Code ATX M02A A65.

Pharmacological properties.

Pharmacodynamics

Algozan® - a combined drug containing a non-steroidal anti-inflammatory drug (NSAID) - diclofenac diethylamine and an angioprotective agent - horse chestnut seed extract. The overall effect of these components in the drug leads to the weakening or elimination of pain and inflammation, helps to increase the range of motion in the affected joints and reduce morning stiffness, accelerates the disappearance of post-traumatic hematomas, edema, and prevents blood stasis in case of venous insufficiency.

Diclofenac diethylamine. It blocks the synthesis of prostaglandins, eliminates or significantly reduces the severity of the symptoms of inflammation, reduces the increased sensitivity of nerve endings to mechanical and biologically active substances that form on the site of inflammation; penetrates well through the skin and accumulates in adjacent tissues, penetrates into the area of ​​inflammation.

Chestnut horse seed extract dry. Escin. Escin is a natural mixture of triterpene saponins, which are obtained from horse chestnut seeds (Aesculus hippocastanum L.), which have decongestant, venotonic, and anti-inflammatory activity. In addition, escin acts at the initial stage of the inflammatory process, which is associated with increased membrane and capillary permeability and the production of exudate in adjacent tissues.

Escin has an anti-serotonin and antihistamine effect.

Escin inhibits the activity of prostaglandinsynthetase. This enzyme is necessary for the formation of prostaglandins, which play an important role in the mechanism of inflammation.

Escin prevents the decrease in the content of adenosine triphosphoric acid (ATP) in endothelial cells and increases the activity of phospholipase A2, an enzyme responsible for the release of precursors of inflammatory mediators. Escin reduces the activity of lysosomal enzymes that break down the proteoglycans contained in the walls of capillaries. This increases the resistance of capillaries, reduces their permeability, thereby reducing the amount of exudate and the formation of edema.

Pharmacokinetics

The amount of diclofenac that is absorbed through the skin is proportional to the area of ​​its application and depends on the total dose of the drug used and on the degree of skin hydration. After topical application of 2.5 g of the drug to the skin surface with an area of ​​500 cm2 the absorption rate of diclofenac is approximately 6%. Diclofenac diethylamine binds to serum proteins by 99.7%, mainly with albumin (99.4%), penetrates the synovial fluid (half-life from synovial fluid is 3-6 hours), penetrates the placenta and the blood-brain barrier, is excreted in the urine .

Aescin is well absorbed by tissues, its maximum plasma concentration is reached after 2-3 hours, it is metabolized in the liver.It is excreted mainly with bile in the form of metabolites, to a lesser extent - with urine. The elimination half-life is up to 20 hours.

Clinical characteristics.

Indications.

Symptomatic treatment of pain, inflammation and swelling with:

  • soft tissue damage: injuries of tendons, ligaments, muscles and joints (due to dislocation, sprain, bruising); sports injuries;
  • localized forms of soft tissue rheumatism: tendonitis (including “tennis player’s elbow”), bursitis, shoulder syndrome and periarthropathy; localized forms of degenerative rheumatism (osteoarthritis of the peripheral joints and spine).

Symptomatic therapy for diseases and symptoms caused by impaired peripheral circulation:

  • phlebeurysm;
  • swelling of the legs and pain associated with venous insufficiency;
  • post-traumatic hematomas and hematomas after injections and infusions.

Contraindications

Hypersensitivity to diclofenac or other components of the drug, renal failure, impaired hematopoiesis; the presence of erosive and ulcerative lesions of the gastrointestinal tract.

The presence of a history of asthma attacks, angioedema, urticaria or acute rhinitis due to the use of acetylsalicylic acid or other NSAIDs.

The drug is contraindicated during pregnancy or lactation.

Interaction with other drugs and other types of interactions.

When using the gel, you cannot simultaneously apply other drugs to the same area of ​​the skin.

Diclofenac contained in the drug potentiates the specific effects of oral drugs from the NSAID group when used simultaneously, also the ulcerogenic effect of corticosteroids; increases the concentration of digoxin and lithium in the blood; weakens the action of diuretics and saluretics of the thiazide and furosemide groups.

The therapeutic effectiveness with the use of a gel with salicylates is reduced, while the ulcerogenic effect on the gastric mucosa is enhanced.

With simultaneous use with coagulants and anticoagulants, the state of the blood coagulation system should be monitored.

Since Algozan® contains escin in the composition of chestnut horse seeds of dry extract, it is not used in combination with drugs that inhibit ovulation.

Features of the application.

Before use, consult a doctor.

Do not use dosage higher than recommended.

The gel should be applied only to undamaged skin, avoiding contact with inflamed, wounded or infected skin. Contact of the drug with eyes and mucous membranes should be avoided. The drug should not be swallowed.

Do not rub during application.

The likelihood of developing systemic side effects (which occur when using systemic forms of diclofenac) should be considered when using the drug on larger areas of the skin or for a longer time than recommended. In such cases, it is necessary to use the drug with caution to patients who have hepatic, renal or heart failure, a history of hematopoietic system diseases, as well as peptic ulcer disease in the active stage, while using other NSAIDs.

In case of sudden onset of severe symptoms of venous insufficiency (sudden swelling of one or both legs, discoloration of the skin, a feeling of tension and severe pain), especially on one limb, vein thrombosis of the lower extremities should be excluded.

The drug should not be used under an airtight occlusive dressing.

In case of sprain, the affected area can be bandaged with a bandage.

The drug contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which can cause an allergic reaction, including bronchospasm.The product contains propylene glycol, which can cause mild localized skin irritation.

If any skin rash appears, the drug should be discontinued.

Due to the possibility of photosensitivity, direct sunlight and visits to the solarium should be avoided during treatment and for another 2 weeks after discontinuation of treatment.

Use during pregnancy or lactation.

The drug should not be prescribed during pregnancy or lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Does not affect.

Dosage and administration.

Gel for external use.

Daily dose: 2 g of the gel is applied with a thin strip (about 10 cm) on the skin at the site of inflammation (joints, veins and other parts of the body with inflammation and pain, avoiding contact with the damaged skin surface, open wounds, mucous membranes) 2–4 times day. After applying the gel, do not apply an occlusive dressing.

The average daily dose is 4-8 g of gel.

The course of treatment is 14 days. The duration of treatment depends on the severity and course of the disease and is determined by the doctor.

It is necessary to consult a doctor if, after 7 days of treatment, the patients condition has not improved or worsened.

Children.

Not used in pediatric practice.

Overdose.

An overdose is unlikely.

In case of an overdose, allergic reactions (skin itching, rashes, burning), the occurrence of systemic side effects characteristic of diclofenac (generalized skin rashes, angioedema, photosensitivity, headache, drowsiness, dizziness, nausea, impaired gastrointestinal function) are possible.

Treatment: cancel the drug, if excessive amounts of the drug are used, rinse the skin with plenty of cool water, consult a doctor. Symptomatic Therapy

In case of accidental ingestion of the drug, you should immediately empty the stomach and take an adsorbent, consult a doctor. Symptomatic treatment with the use of therapeutic measures that are used to treat poisoning with non-steroidal anti-inflammatory drugs is recommended. Symptomatic Therapy

Adverse Reactions

In places of application, slight transient reactions on the skin are possible.

In rare cases, allergic reactions occur.

Infections and infestations: pustular rashes.

On the part of the immune system: hypersensitivity reactions, angioedema.

From the respiratory system: bronchial asthma.

On the part of the skin and its appendages: rashes, erythema, eczema, dermatitis; bullous dermatitis; photosensitization reactions, itching, rashes, burning.

If these symptoms occur, discontinue treatment and consult a doctor.

Shelf life.

2 years.

Do not use after the expiration date indicated on the package.

Storage conditions.

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Packaging.

35 g per tube.

1 tube in a pack of cardboard.

Vacation category.

Over the counter.

Manufacturer.

Pao "chemical farm" red star ".

The location of the manufacturer and the address of the place of business.

61010, Ukraine, Kharkov, st. Gordienkovo, 1.

Tags: Algozan® [Diclofenac, Escin]